FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents ... (e reactions ( 1%) which were suspected o...)

FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults

Date:1/24/2008

e reactions (> 1%) which were suspected or probably drug- related were vaginal yeast infection (2.0%), diarrhea (1.7%), nausea (1.3%), and headache (1.0%).

Safety and effectiveness of MOXATAG in pediatric patients less than 12 years of age has not been established.

About MOXATAG(TM):

MOXATAG (amoxicillin extended-release tablets) is a once-a-day extended- release formulation of amoxicillin for oral administration consisting of three components: one immediate-release and two delayed-release. The three components are combined in a specific ratio to prolong the release of amoxicillin from MOXATAG compared to immediate-release amoxicillin.

MOXATAG is intended to provide a lower treatment dose, once-daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis. MiddleBrook utilized its proprietary PULSYS(R) once-daily pulsatile delivery technology to develop MOXATAG. The company currently has a total of 26 issued U.S. patents and two issued foreign patents covering its PULSYS technology. Patents specifically relating to MOXATAG run to 2020.

Amoxicillin is indicated for a broad range of infections, and is commonly prescribed as a first-line therapy for common infections such as otitis media (middle ear infection), pharyngitis (sore throat), and sinusitis (sinus infection). Group A streptococcus, the primary bacteria causing pharyngitis, have been uniformly susceptible to amoxicillin and have not developed resistance to the penicillins, despite the long-term use of amoxicillin for pharyngitis.

According to data from IMS Health, a pharmaceutical research company, approximately one-quarter of amoxicillin prescriptions are written for pharyngitis, strep throat, and tonsillitis in adults and children. Approximately 60 million prescriptions for amoxicillin were written in 2006 with total retail sales of more than $650
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FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents ...(e reactions ( 1%) which were suspected o...),Health